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Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
NSCLC

Thank you

Trial Information

Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research


Patients will be randomized to 2 groups


Inclusion Criteria:



1. 18~70 years

2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV
non-small cell lung cancer

3. Presence of at least one index lesion measurable by CT scan or MRI

4. Ecog0-1

5. Expected life time longer than 12 weeks

6. Normal laboratory values:

- leucocyte ≥ 4×109/L

- neutrophil ≥ 1.5×109/L

- platelet ≥ 100×109/L

- Hemoglobin ≥ 10g/L

- ALT and

- AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)

7. Signed written informed consent

Exclusion Criteria:

- Patients have used drugs according to protocol

- Patients were allergic to pemetrexed or cisplatin

- Patients received radiotherapy or other biological treatment 4 weeks before the trial

- Uncontrolled hydrothorax or hydropericardium

- neuropathy toxicity ≥ CTC 3

- Severe symptomatic heart disease

- Active upper gastrointestinal ulcer or digestive disfunction

- Severe infection or metabolic disfunction

- Patients with other malignant tumor

- Uncontrolled brain metastases

- Patients have accepted other clinical trials

- Female patients during their pregnant and lactation period, or patients without
contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

12 weeks of non-progression rate

Outcome Time Frame:

from the first cycle of treatment (day one) to two month after the last cycle

Safety Issue:

No

Principal Investigator

Chang jian hua, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer hospital Fudan University

Authority:

China: Ethics Committee

Study ID:

Gefitinib-2009-cjh

NCT ID:

NCT01769066

Start Date:

December 2009

Completion Date:

Related Keywords:

  • NSCLC

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